- Pfizer submitted its application to the FDA for emergency use authorization of its COVID-19 pill on Tuesday
- The pill called Paxlovid works by inhibiting an enzyme that the coronavirus uses to make copies of itself inside human cells.
- Clinical trial data has shown the drug can cut hospitalization and death rates from the virus by nearly 90%
- It comes on the same day that Pfizer signed a deal with the United Nations-backed group Medicines Patent Pool to allow generic drug companies to produce the pill for use in 95 countries.
Pfizer Inc. on Tuesday submitted an application with the US Food and Drug Administration for emergency use authorization of its COVID-19 pill.
Recent clinical trial data found that the drug can cut the rate of hospitalization and death from the virus by about 90 percent.
Additionally, it could become an important tool in cities and countries that have limited access to vaccines or low vaccination rates.
Pfizer CEO Albert Boerla said earlier today that the company plans to submit the data to the FDA before Thanksgiving.
Pfizer submitted its application to the FDA for emergency use authorization of its COVID-19 pill on Tuesday (file image)
The pill called Paxlovid (above) works by inhibiting an enzyme that the coronavirus uses to make copies of itself inside human cells.
Pfizer’s candidate, called paxlovid, belongs to a class of drugs known as protease inhibitors.
The pill will work by inhibiting an enzyme that the coronavirus uses to make copies of itself inside human cells.
The company said the protease inhibitors have been effective in treating other viral pathogens such as HIV and hepatitis C virus, both on their own and in combination with other antivirals.
Earlier this month, the drugmaker released preliminary results of its study of 775 adults who had contracted mild to moderate COVID-19.
Not all participants had been vaccinated and were considered to be at high risk of hospitalization due to underlying conditions, including obesity and diabetes.
Patients were treated within three to five days of reporting their first symptoms and for a total of five days.
Patients taking Pfizer’s drug along with an antiviral HIV drug saw an 89 percent lower risk of hospitalization or death after one month, compared with the placebo group.
Only 0.8 percent of patients taking the drug required hospitalization and none died.
In the comparison group, seven percent were hospitalized and seven deaths occurred.
Pfizer didn’t give side effects in great detail but said rates were about 20 percent in each group.
Pfizer Inc. released results of clinical trials earlier this month showing that its antiviral pill reduced hospitalizations and mortality by 89%.
The results of the study were so impressive that Pfizer withdrew it early to seek approval for its use.
This is the second pill to be proven effective in treating the disease, after Merck & Co. announced last month that its experimental antiviral could cut the risk of serious illness and death in half.
Merck’s pill has since been given the green light by the UK and is expected to be approved by the FDA during a meeting on 30 November.
It’s unclear how soon the FDA will approve Pfizer’s pill.
Pfizer has also submitted for regulatory approval in Australia, New Zealand and South Korea, with plans to submit applications in more countries.
“We are moving forward as quickly as possible in our effort to get this potential treatment into the hands of patients, and we look forward to working with the FDA on a review of our application, along with other regulatory agencies around the world.” Borla said. in a news release.
The news comes on the same day that Pfizer announced it has signed a deal with the United Nations-backed group to let other companies manufacture its own COVID-19 pill.
The deal with Geneva-based Medicines Patent Pool will allow generic drug companies to produce the pill so that it can be supplied to 95 low- and middle-income countries.
What’s more, Pfizer will not receive royalties on any sales in low-income countries and royalties will be waived on sales in all countries covered under the agreement, as long as the coronavirus is considered a public health emergency.